The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2018-01998.
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The patient was undergoing a coil embolization procedure in the portal vein using a pod8 and a penumbra coil 400 detachment handle (handle).During the procedure, the physician advanced a pod8 into the target vessel and used a handle to detach it; however, the pod8 failed to detach.The physician then made three to four additional attempts but the pod8 would still not detach.It was reported that the black alignment zone (pet lock) was not separated.The procedure was completed using another handle and the same pod8.There was no report of an adverse effect to the patient.
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